SPA DRY HEEL FOOT RELIEF- dimethicone cream 
Jafra Cosmetics International Inc

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Active ingredient

Dimethicone 4%

Purpose

Skin protectant

Uses

Warning

For external use only
When using this product● do not get into eyes
Stop use and ask a doctor● condition worsens ● symptoms last more than 7 days or clear up and occur again in a few days
Do not use on● deep or puncture wounds ● animal bites ● serious burns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direction


• apply as needed

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Polyisobutene, Butyrospermum Parkii (Shea) Butter, Stearyl Stearate, Isopropyl Palmitate, Cetearyl Alcohol, Cetyl Alcohol, Di-PPG-3 Myristyl Ether Adipate, Myristyl Myristate, Ceteareth-20, Behenyl Alcohol, Niacinamide, Sodium PCA, Lactic Acid, Olea Europaea (Olive) Fruit Oil, Fragrance, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Allantoin, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Phytosterols, Ethylhexylglycerin, Hexylene Glycol, Panthenol, Disodium EDTA

Product label

image description

SPA DRY HEEL FOOT RELIEF 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYISOBUTYLENE (55000 MW) (UNII: TQ77WR8A02)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARYL STEARATE (UNII: 5WX2EGD0DK)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
DOCOSANOL (UNII: 9G1OE216XY)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALLANTOIN (UNII: 344S277G0Z)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PANTHENOL (UNII: WV9CM0O67Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-002-011 in 1 CARTON06/01/2022
1115 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01606/01/2022
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-002)

Revised: 12/2023
Document Id: 0daad028-416a-b080-e063-6294a90a14b7
Set id: ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9
Version: 3
Effective Time: 20231229
 
Jafra Cosmetics International Inc